Trial Outcomes & Findings for Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT00625586)
NCT ID: NCT00625586
Last Updated: 2023-11-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
8 months
Results posted on
2023-11-03
Participant Flow
Patient recruitment was conducted by two cancer institutes between April and July 2008.
Participant milestones
| Measure |
RAV12 Plus Gemcitabine
RAV12 monoclonal antibody plus gemcitabine
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
RAV12 Plus Gemcitabine
RAV12 monoclonal antibody plus gemcitabine
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Progressive disease
|
1
|
Baseline Characteristics
Monoclonal Antibody RAV12 and Gemcitabine in Treating Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
RAV12 Plus Gemcitabine
n=2 Participants
Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 monthsOutcome measures
| Measure |
RAV12 Plus Gemcitabine
n=2 Participants
RAV12 plus standard gemcitabine
|
|---|---|
|
Number of Patients Alive at 8 Months
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The study was terminated at 11 months. There is no 12 month data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsPopulation: Only 1 patient was evaluable for response assessment.
Based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0; partial response = 30% decrease in sum of longest diameter. complete response = 100% decrease in sum of longest diameter. Rate of response = proportion of complete or partial responses based on number of patients evaluated.
Outcome measures
| Measure |
RAV12 Plus Gemcitabine
n=1 Participants
RAV12 plus standard gemcitabine
|
|---|---|
|
Partial Response and Complete Response Rates
|
0 participants
|
SECONDARY outcome
Timeframe: up to 11 monthsTime from the first dose date to the date of first documented progression or death from any cause, whichever occurs first.
Outcome measures
| Measure |
RAV12 Plus Gemcitabine
n=2 Participants
RAV12 plus standard gemcitabine
|
|---|---|
|
Median Progression-free Survival
|
4.5 months
Standard Deviation 4.94
|
SECONDARY outcome
Timeframe: up to 11 monthsPopulation: Survival data is only available for 1 patient. The second patient was known to be alive at 9 months but lost to follow up. Median overall survival cannot be calculated.
Time from the first dose date to the date of death from any cause
Outcome measures
| Measure |
RAV12 Plus Gemcitabine
n=2 Participants
RAV12 plus standard gemcitabine
|
|---|---|
|
Median Overall Survival
|
NA months
Median overall survival could not be calculated due to an insufficient number of events
|
SECONDARY outcome
Timeframe: Throughout the study, up to 11 monthsFrequency of adverse events and serious adverse events
Outcome measures
| Measure |
RAV12 Plus Gemcitabine
n=2 Participants
RAV12 plus standard gemcitabine
|
|---|---|
|
Participants With Adverse Events
|
2 participants
|
SECONDARY outcome
Timeframe: 29 daysRAV12 and gemcitabine cmax
Outcome measures
| Measure |
RAV12 Plus Gemcitabine
n=2 Participants
RAV12 plus standard gemcitabine
|
|---|---|
|
Cmax
|
NA mcg/mL
Standard Deviation NA
Cmax could not be calculated due to insufficient number of samples
|
Adverse Events
RAV12 Plus Gemcitabine
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
RAV12 Plus Gemcitabine
n=2 participants at risk
Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
General disorders
Leg pain
|
50.0%
1/2 • Throughout the study, up to 11 months
|
|
General disorders
Edema
|
50.0%
1/2 • Throughout the study, up to 11 months
|
Other adverse events
| Measure |
RAV12 Plus Gemcitabine
n=2 participants at risk
Escalating doses of RAV12, plus standard gemcitabine at 1000 mg/m2 iv over 30 min., weekly days 1, 8, 15, 22 of the first cycle and 1000 mg/m2 iv over 30 min., weekly days 1, 8, and 15 of each subsequent cycle of 28 days
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Ascites
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Gingival bleeding
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 3 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Odynophagia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Oral pain
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Stomatitis
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
General disorders
Asthenia
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
General disorders
Chest discomfort
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
General disorders
Influenza like illness
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Infections and infestations
Furuncle
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Injury, poisoning and procedural complications
Joint sprain
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Investigations
Haemoglobin decreased
|
100.0%
2/2 • Number of events 4 • Throughout the study, up to 11 months
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 4 • Throughout the study, up to 11 months
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • Number of events 6 • Throughout the study, up to 11 months
|
|
Investigations
Urine colour abnormal
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Investigations
Weight decreased
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Investigations
White blood cell count decreased
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
100.0%
2/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 3 • Throughout the study, up to 11 months
|
|
Renal and urinary disorders
Dysuria
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • Number of events 2 • Throughout the study, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1 • Throughout the study, up to 11 months
|
|
General disorders
Oedema peripheral
|
100.0%
2/2 • Number of events 2 • Throughout the study, up to 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place